Procedure : 2017/0328(COD)
Document stages in plenary
Document selected : A8-0063/2018

Texts tabled :

A8-0063/2018

Debates :

Votes :

PV 15/03/2018 - 10.8
CRE 15/03/2018 - 10.8
PV 25/10/2018 - 13.11

Texts adopted :

P8_TA(2018)0086
P8_TA(2018)0427

REPORT     ***I
PDF 687kWORD 79k
12 March 2018
PE 615.463v02-00 A8-0063/2018

on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency

(COM(2017)0735 – C8-0421/2017 – 2017/0328(COD))

Committee on the Environment, Public Health and Food Safety

Rapporteur: Giovanni La Via

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 STATEMENT OF THE EUROPEAN PARLIAMENT
 EXPLANATORY STATEMENT
 OPINION of the Committee on Constitutional Affairs
 PROCEDURE – COMMITTEE RESPONSIBLE
 FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency

(COM(2017)0735 – C8-0421/2017 – 2017/0328(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0735),

–  having regard to Article 294(2) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0421/2017),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Constitutional Affairs (A8-0063/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Denounces the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 19 July 2012 and the Common Approach annexed to it and calls for close involvement of the European Parliament in the decision-making process on the location and relocation of agencies and bodies in view of its prerogatives as co-legislator under the ordinary legislative procedure;

3.  Approves its statement annexed to this resolution;

4.  Regrets that the European Parliament - and ultimately the representatives of the Union’s citizens - were not fully involved in the procedure to select the new seat of the European Medicines Agency (EMA), which was eventually concluded by drawing lots, despite it being such an important decision; decisions in relation to the location of bodies and agencies need, and legally must, be taken under the ordinary legislative procedure, fully respecting the European Parliament's prerogatives, whereby the European Parliament and the Council are equal co-legislators;

5.  Regrets the decision of the Council which leads to a deepening of the geographical disproportionality with only 9 out of 37 EU decentralised agencies being located in new Member States contrary to the European Council Conclusions 5381/04 and 11018/1/08 which both give priority to new Member States.

6.  Calls on the budgetary authorities and the Commission to ensure that the costs relating to the change in the seat of EMA will be fully covered by the current host country; points out that some of the costs of the relocation from the current location will have to be pre-financed by the Union budget, prior to the financial settlement with the current host country;

7.  Calls on the budgetary authorities and the Commission to ensure that the costs relating to the change in the seat of the EMA will be fully covered by the current host country;

8.  Calls on the budgetary authorities and the Commission to ensure that the additional costs relating to the double transfer of the seat of EMA, first to a temporary location, and then to the Vivaldi Building, will be fully covered by the Dutch government and thus will not adversely affect the general budget of the Union;

9.  Calls on the budgetary authorities and the Commission to ensure that the double transfer will not jeopardise the normal operational needs of EMA, and will guarantee business continuity and EMA’s smooth functioning, without disruption, beyond March 2019;

10.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

11.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment    1

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2)  Having regard to Article 50(3) of the Treaty on European Union, the European Medicines Agency should take its new seat as from the date on which the Treaties cease to apply to the United Kingdom or from 30 March 2019, whichever is the earlier.

(2)  Having regard to Article 50(3) of the Treaty on European Union (TEU), the European Medicines Agency should take its new seat from 30 March 2019.

Justification

The date of 30 March 2019 is the date when the UK is expected to become a third country. Although the Commission’s proposal reflects the legal possibility that the UK could leave the Union before the end of the 2 years period foreseen in Art 50, the Agency requires legal certainty as regards the official date of its departure from the UK for several practical reasons related to the planning of its relocation process. To avoid that the Agency would have to suddenly move earlier than currently planned, e.g. due to a collapse in the EU-UK negotiations, the Agency would not be in a position to complete all necessary relocation activities on time.

Amendment    2

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3)  To ensure the proper functioning of the European Medicines Agency in its new location, a headquarters agreement should be concluded before the European Medicines Agency takes up its new seat.

(3)  To ensure the proper functioning of the European Medicines Agency in its new location, a headquarters agreement should be concluded as soon as possible. The headquarters agreement should include the most appropriate terms and conditions for the successful relocation of the European Medicines Agency and its staff members to Amsterdam.

Justification

Having a precise timeline in the legislation for the signature of the headquarters agreement is required to prevent delays in the HQ agreement's negotiations and thus to support the preparatory activities for the relocation by 30 March 2019.The existence of an HQ agreement setting out a detailed framework for the Agency's installation in the new host country will reduce uncertainty and provide additional clarity to staff members, thus helping to guarantee business continuity during all phases of the relocation.

Amendment    3

Proposal for a regulation

Recital 3 a (new)

 

Text proposed by the Commission

Amendment

 

(3a)  In order to ensure the Agency’s full business continuity, the temporary location in Amsterdam should be provided as of 1 January 2019 and the permanent headquarters of the Agency should be completed by 15 November 2019.

Amendment    4

Proposal for a regulation

Recital 3 b (new)

 

Text proposed by the Commission

Amendment

 

(3b)  It is to be welcomed that the new location of the Agency is in line with the preferences of its current staff members and that the Dutch authorities are making efforts to ensure that the double transfer will not jeopardise the operational effectiveness, continuity and uninterrupted functioning of the Agency. However, the double relocation of the Agency to Amsterdam means that the Agency will have to temporarily de-prioritise certain activities, such as its work on paediatric medicines and public health issues including its work on anti-microbial resistance and flu pandemics, while it resides in the temporary location. The delays that the Dutch government has already announced, which have pushed back the handover of the permanent building, on which construction work has not yet started, raise concerns about potential further delays. The relocation to the temporary building should be limited to 10.5 months to ensure that the Agency will be able to operate again at its full capacity as of 16 November 2019 and avoid further loss of expertise

Amendment    5

Proposal for a regulation

Article 1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

In Regulation (EC) No 726/2004, the following Article 71a is inserted:

In Regulation (EC) No 726/2004, the following Article 71a and Article 71b are inserted:

Amendment    6

Proposal for a regulation

Article 1 – paragraph 1

Regulation (EC) No 726/2004

Article 71a

 

Text proposed by the Commission

Amendment

Article 71a

Article 71a

The Agency shall have its seat in Amsterdam, the Netherlands.

The Agency shall have its seat in Amsterdam, the Netherlands.

 

The Commission and the competent authorities of the Netherlands shall take all necessary measures to ensure that the Agency can move to its temporary location no later than 1 January 2019 and that it can move to its permanent location no later than 16 November 2019..

 

The Commission and the competent authorities of the Netherlands shall submit a written report to the European Parliament and the Council on the progress on the adjustments of the temporary premises and on the construction of the permanent building three months after the entry into force of this Regulation, and every three months thereafter, until the Agency has moved into its permanent headquarters.

Amendment    7

Proposal for a regulation

Article 1 – paragraph 1 – introductory part

Regulation (EC) No 726/2004

Article 71 b (new)

 

Text proposed by the Commission

Amendment

 

Article 71b

 

A headquarters agreement allowing the Agency to take up its duties at the premises approved by the European Parliament and the Council shall be concluded within three months from the date this Regulation enters into force.

Justification

Having a precise timeline in the legislation for the signature of the headquarters agreement is required to prevent delays in the HQ agreement's negotiations and thus to support the preparatory activities for the relocation by 30 March 2019.The existence of an HQ agreement setting out a detailed framework for the Agency's installation in the new host country will reduce uncertainty and provide additional clarity to staff members, thus helping to guarantee business continuity during all phases of the relocation.

Amendment    8

Proposal for a regulation

Article 2 – paragraph 2

Text proposed by the Commission

Amendment

This Regulation shall apply from the date on which the Treaties cease to apply to the United Kingdom or from 30 March 2019, whichever is the earlier.

This Regulation shall apply from 30 March 2019.

Justification

The date of 30 March 2019 is the date when the UK is expected to become a third country. Although the Commission’s proposal reflects the legal possibility that the UK could leave the Union before the end of the 2 years period foreseen in Art 50, the Agency requires legal certainty as regards the official date of its departure from the UK for several practical reasons related to the planning of its relocation process. To avoid that the Agency would have to suddenly move earlier than currently planned, e.g. due to a collapse in the EU-UK negotiations, the Agency would not be in a position to complete all necessary relocation activities on time.


STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament regrets that its role of co-legislator has not been duly taken into account since it was not involved in the procedure leading to the selection of the new seat of the European Medicines Agency.

The European Parliament wishes to recall its prerogatives as co-legislator and insists on the full respect of the ordinary legislative procedure in relation to the location of bodies and agencies.

As the only directly elected Union institution and representative of the Union’s citizens, it is the first guarantor of the respect of the democratic principle in the Union.

The European Parliament condemns the procedure followed for the selection of the new location of the seat, which has de facto deprived the European Parliament of its prerogatives since it was not effectively involved in the process, but is now expected to simply confirm the selection made for the new location of the seat by means of the ordinary legislative procedure.

The European Parliament recalls that the Common Approach annexed to the Joint Statement of the European Parliament, Council and European Commission on decentralised agencies signed in 2012 is legally non-binding, as acknowledged in the Statement itself and that it was agreed without prejudice to the legislative powers of the institutions.

Therefore, the European Parliament insists that the procedure followed for the selection of a new location for the agencies will be revised and not used anymore in this form in the future.

Finally, the European Parliament wishes to recall as well that in the Inter-institutional Agreement on Better Law-Making of 13 April 2016(1) the three institutions committed to sincere and transparent cooperation while recalling the equality of both co-legislators as enshrined in the Treaties.

(1)

OJ L 123, 12.5.2016, p. 1.


EXPLANATORY STATEMENT

The European Medicines Agency (EMA) is an important EU decentralised Agency, responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

The EU's health and safety needs are constantly evolving, resulting in an increasing demand of information and of a risk and evidence-based perspective.

Therefore, EMA’s mission to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union, is and will be of utmost importance.

The Agency, currently based in London, has to be relocated in the context of the UK's withdrawal from the EU. On 22 June 2017, in the margins of the European Council, the EU27 leaders endorsed a specific procedure for the relocation of this agency and EBA’s. EU27 ministers voted in the margins of the General Affairs Council meeting on 20 November 2017, assigning the location with a draw to Amsterdam, the Netherlands.

On 29 November 2017, the European Commission proposed a legislative amendment for the relocation of the European Medicines Agency, under the ordinary legislative procedure, asking the co-legislators (the European Parliament and the Council) to give priority to the handling of the legislative proposal, which is strictly limited to confirming the new seat of the Agency in the founding Regulation.

The offer from the Netherlands indicates one proposed building, the Vivaldi Building (31,855 m²), which according to the offer, has a planned delivery of the conference centre as well as some of the workplaces by 1 April 2019, with consecutive office floors becoming available up to 6 months later. The offer also indicates temporary back up premises to be used as of 1st January 2019 until all EMA staff has moved to the Vivaldi Building, with a detailed layout to be agreed with the Agency.

The Rapporteur regrets that the European Parliament, and ultimately the EU citizen representatives, were not fully involved in the procedure to select the new seat of EMA, which was eventually concluded by a draw, despite it being such an important decision.

The rapporteur intends, therefore, to propose to work towards a Declaration, as an annex to the report to be voted in ENVI Committee and in plenary, in order to modify the Joint Statement of the European Parliament, Council and European Commission on decentralised agencies and the Common Approach annex to the document, signed in 2012, which are legally non-binding, as written in the Statement itself, and agreed without prejudice to the legislative power of the Institutions.

The rapporteur intends to defend the prerogatives of the European Parliament and believes that all decisions in relation to the location of EU bodies and agencies need and have to- legally- be taken under the ordinary legislative procedure, fully respecting the European Parliament's prerogatives, whereby the European Parliament and the Council are equal co-legislators.


OPINION of the Committee on Constitutional Affairs (27.2.2018)

for the Committee on the Environment, Public Health and Food Safety

on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency

(COM(2017)0735 – C8-0421/2017 – 2017/0328(COD))

Rapporteur: Mercedes Bresso

AMENDMENTS

The Committee on Constitutional Affairs calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take into account the following amendments:

Amendment  1

Draft legislative resolution

Paragraph 1 a (new)

Draft legislative resolution

Amendment

 

1a.   Calls for an immediate review of the Common Approach annexed to the Joint Statement of the European Parliament, the Council of the European Union and the European Commission on decentralised agencies of 19 July 2012 in order to closely involve the European Parliament in the decision-making process on the location of agencies in view of its prerogatives as co-legislator under the ordinary legislative procedure;

Amendment    2

Draft legislative resolution

Paragraph 1 b (new)

Draft legislative resolution

Amendment

 

1b.   Approves its statement annexed to this resolution;

For information, the statement reads as follows:

‘The European Parliament regrets that its role of co-legislator has not been duly taken into account since it was not involved in the procedure leading to the selection of the new seat of the European Medicines Agency (EMA).

The European Parliament wishes to recall its prerogatives as co-legislator and insists on the full respect of the ordinary legislative procedure in relation to the location of bodies and agencies.

As the only directly elected Union institution and representative of the Union’s citizens, it is the first guarantor of the respect of the democratic principle in the Union.

The European Parliament condemns the procedure followed for the selection of the new location of the seat, which has de facto deprived the European Parliament of its prerogatives since it was not effectively involved in the process, but is now expected to simply confirm the selection made for the new location of the seat by means of the ordinary legislative procedure.

The European Parliament recalls that the Common Approach annexed to the Joint Statement of the European Parliament, Council and European Commission on decentralised agencies signed in 2012 is legally non-binding, as acknowledged in the Statement itself and that it was agreed without prejudice to the legislative powers of the institutions.

The European Parliament welcomes that the selection procedure of the new seat of the agency was based on selection criteria referred to in the Common Approach, but deplores that it was eventually concluded by drawing lots. Therefore, the European Parliament insists that the procedure followed for the selection of a new location for the agencies will be reformed and not used anymore in this form in the future.

Finally, the European Parliament wishes to recall as well that in the Inter-institutional Agreement on Better Law-Making of 13 April 20161 the three institutions committed to sincere and transparent cooperation while recalling the equality of both co-legislators as enshrined in the Treaties.’

______________________

OJ L 123, 12.5.2016, p. 1.

Amendment    3

Proposal for a regulation

Citation 1 a (new)

Text proposed by the Commission

Amendment

 

Having regard to the Treaty on European Union, and in particular Article 13(2) thereof,

Justification

Reference to the duty of mutual sincere cooperation amongst EU institutions

Amendment    4

Proposal for a regulation

Recital 5 a (new)

Text proposed by the Commission

Amendment

 

(5 a)   Article 13(2) of the Treaty on European Union requires relations among the institutions of the Union to be carried out in mutual sincere cooperation, while each of them is acting within the limits of the powers conferred on it in the Treaties, and in conformity with the procedures, conditions and objectives set out in them.The European Parliament is to be fully informed and involved throughout all the steps of the ordinary legislative procedure.

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title

Location of the seat of the European Medicines Agency

References

COM(2017)0735 – C8-0421/2017 – 2017/0328(COD)

Committee responsible

       Date announced in plenary

ENVI

11.12.2017

 

 

 

Opinion by

       Date announced in plenary

AFCO

11.12.2017

Rapporteur

       Date appointed

Mercedes Bresso

26.2.2018

Discussed in committee

26.2.2018

 

 

 

Date adopted

26.2.2018

 

 

 

Result of final vote

+:

–:

0:

18

3

1

Members present for the final vote

Mercedes Bresso, Richard Corbett, Pascal Durand, Danuta Maria Hübner, Diane James, Ramón Jáuregui Atondo, Morten Messerschmidt, Maite Pagazaurtundúa Ruiz, Pedro Silva Pereira, Barbara Spinelli, Kazimierz Michał Ujazdowski

Substitutes present for the final vote

Max Andersson, Enrique Guerrero Salom, Sylvia-Yvonne Kaufmann, Jérôme Lavrilleux, Mairead McGuinness, Cristian Dan Preda, Jasenko Selimovic

Substitutes under Rule 200(2) present for the final vote

Eleonora Evi, Seán Kelly, Jeroen Lenaers, Ramón Luis Valcárcel Siso

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

18

+

ALDE

Maite Pagazaurtundúa Ruiz, Jasenko Selimovic

EFDD

Eleonora Evi

GUE/NGL

Barbara Spinelli

PPE

Danuta Maria Hübner, Seán Kelly, Jérôme Lavrilleux, Jeroen Lenaers, Mairead McGuinness, Cristian Dan Preda, Ramón Luis Valcárcel Siso

S&D

Mercedes Bresso, Richard Corbett, Enrique Guerrero Salom, Ramón Jáuregui Atondo, Sylvia-Yvonne Kaufmann

VERTS/ALE

Max Andersson, Pascal Durand

3

-

ECR

Morten Messerschmidt, Kazimierz Michał Ujazdowski

NI

Diane James

1

0

S&D

Pedro Silva Pereira

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention


PROCEDURE – COMMITTEE RESPONSIBLE

Title

Location of the seat of the European Medicines Agency

References

COM(2017)0735 – C8-0421/2017 – 2017/0328(COD)

Date submitted to Parliament

29.11.2017

 

 

 

Committee responsible

       Date announced in plenary

ENVI

11.12.2017

 

 

 

Committees asked for opinions

       Date announced in plenary

BUDG

11.12.2017

CONT

11.12.2017

ITRE

11.12.2017

AGRI

11.12.2017

 

AFCO

11.12.2017

 

 

 

Not delivering opinions

       Date of decision

BUDG

11.12.2017

ITRE

23.1.2018

AGRI

13.12.2017

 

Rapporteurs

       Date appointed

Giovanni La Via

10.1.2018

 

 

 

Discussed in committee

25.1.2018

 

 

 

Date adopted

12.3.2018

 

 

 

Result of final vote

+:

–:

0:

52

6

1

Members present for the final vote

Margrete Auken, Pilar Ayuso, Ivo Belet, Biljana Borzan, Paul Brannen, Soledad Cabezón Ruiz, Nessa Childers, Birgit Collin-Langen, Miriam Dalli, Seb Dance, Angélique Delahaye, Bas Eickhout, José Inácio Faria, Karl-Heinz Florenz, Francesc Gambús, Elisabetta Gardini, Gerben-Jan Gerbrandy, Arne Gericke, Jens Gieseke, Julie Girling, Françoise Grossetête, Andrzej Grzyb, György Hölvényi, Anneli Jäätteenmäki, Karin Kadenbach, Kateřina Konečná, Giovanni La Via, Peter Liese, Jiří Maštálka, Susanne Melior, Miroslav Mikolášik, Rory Palmer, Piernicola Pedicini, Bolesław G. Piecha, Pavel Poc, Frédérique Ries, Daciana Octavia Sârbu, Annie Schreijer-Pierik, Davor Škrlec, Estefanía Torres Martínez, Nils Torvalds, Adina-Ioana Vălean, Jadwiga Wiśniewska, Damiano Zoffoli

Substitutes present for the final vote

Renata Briano, Nicola Caputo, Jørn Dohrmann, Eleonora Evi, Christofer Fjellner, Jan Huitema, Merja Kyllönen, Norbert Lins, Gesine Meissner, Alojz Peterle, Christel Schaldemose, Carlos Zorrinho

Substitutes under Rule 200(2) present for the final vote

Angelo Ciocca, Emilian Pavel, Massimiliano Salini

Date tabled

12.3.2018


FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

52

+

ALDE

Gerben-Jan Gerbrandy, Jan Huitema, Anneli Jäätteenmäki, Gesine Meissner, Frédérique Ries, Nils Torvalds

ECR

Arne Gericke, Bolesław G. Piecha, Jadwiga Wiśniewska

EFDD

Eleonora Evi, Piernicola Pedicini

GUE/NGL

Kateřina Konečná, Merja Kyllönen, Jiří Maštálka, Estefanía Torres Martínez

PPE

Pilar Ayuso, Ivo Belet, Birgit Collin-Langen, Angélique Delahaye, José Inácio Faria, Christofer Fjellner, Karl-Heinz Florenz, Francesc Gambús, Jens Gieseke, Julie Girling, Françoise Grossetête, Andrzej Grzyb, György Hölvényi, Giovanni La Via, Peter Liese, Norbert Lins, Miroslav Mikolášik, Alojz Peterle, Annie Schreijer-Pierik, Adina-Ioana Vălean

S&D

Biljana Borzan, Paul Brannen, Soledad Cabezón Ruiz, Nessa Childers, Miriam Dalli, Seb Dance, Karin Kadenbach, Susanne Melior, Rory Palmer, Emilian Pavel, Pavel Poc, Christel Schaldemose, Daciana Octavia Sârbu, Carlos Zorrinho

VERTS/ALE

Margrete Auken, Bas Eickhout, Davor Škrlec

6

-

ECR

Jørn Dohrmann

PPE

Elisabetta Gardini, Massimiliano Salini

S&D

Renata Briano, Nicola Caputo, Damiano Zoffoli

1

0

ENF 

Angelo Ciocca

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention

Last updated: 13 March 2018Legal notice